A Phase 1, Double-blind Study to Evaluate the Safety and Tolerability of a Single-dose Administration of IBI355 in Health Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Incidence of AE、SAE after receiving IBI 355
研究概览
简要总结
This study is being done to find out if IBI355 is safe and tolerance in health volunteers. The study will test increasing single doses of IBI355 given to adult health volunteers. The goal is to confirmed the safety of the highest dose of IBI355 or to find out the highest dose of IBI35 that can be given to health volunteer that dose not cause unacceptable side effects. Different dose regimens will be evaluated. The pharmacokinetics and ADA of IBI355 will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who have decided to voluntarily participate in the study and provided a written consent regarding observance of precautions after having been informed of and having fully understood the objectives, methods, and effects of the study in detail;
- •Healthy male and female aged 18 years or above ;
- •Subject with a Body Mass Index (BMI)* between 18.5 and 28.0 kg/㎡;
- •subjects with a normal laboratory examination，ECG， X-ray.
排除标准
- •Subjects with a history of allergy；
- •Subjects participated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)；
- •Subjects with an infection requiring systemic medication was present within 30 days prior to randomization;
- •HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive;
- •There have a clinical or imaging evidence that the subject with active tuberculosis, or there is evidence that the subject is in the incubation period for tuberculosis;
- •Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases;
- •Subject with a hcg positive;
- •Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial
研究组 & 干预措施
IBI355 dose 6
IBI355 25mg/kg and placebo will be given to the subjects (6:2)
干预措施: IBI355 (Drug)
IBI355 dose 1
IBI355 0.3mg/kg and placebo will be given to the subjects (3:2)
干预措施: placebo (Drug)
IBI355 dose 1
IBI355 0.3mg/kg and placebo will be given to the subjects (3:2)
干预措施: IBI355 (Drug)
IBI355 dose 4
IBI355 7.5mg/kg and placebo will be given to the subjects (6:2)
干预措施: placebo (Drug)
IBI355 dose 4
IBI355 7.5mg/kg and placebo will be given to the subjects (6:2)
干预措施: IBI355 (Drug)
IBI355 dose 6
IBI355 25mg/kg and placebo will be given to the subjects (6:2)
干预措施: placebo (Drug)
IBI355 dose 7
IBI355 35mg/kg and placebo will be given to the subjects (6:2)
干预措施: placebo (Drug)
IBI355 dose 7
IBI355 35mg/kg and placebo will be given to the subjects (6:2)
干预措施: IBI355 (Drug)
IBI355 dose 2
IBI355 1mg/kg and placebo will be given to the subjects (6:2)
干预措施: placebo (Drug)
IBI355 dose 2
IBI355 1mg/kg and placebo will be given to the subjects (6:2)
干预措施: IBI355 (Drug)
IBI355 dose 3
IBI355 3mg/kg and placebo will be given to the subjects (6:2)
干预措施: placebo (Drug)
IBI355 dose 3
IBI355 3mg/kg and placebo will be given to the subjects (6:2)
干预措施: IBI355 (Drug)
IBI355 dose 5
IBI355 15mg/kg and placebo will be given to the subjects (6:2)
干预措施: placebo (Drug)
IBI355 dose 5
IBI355 15mg/kg and placebo will be given to the subjects (6:2)
干预措施: IBI355 (Drug)
结局指标
主要结局
Incidence of AE、SAE after receiving IBI 355
时间窗: week 0-12
次要结局
- Area Under Curve, (AUC）、Maximum serum concentration of drug(Cmax）、Clearance (CL）、Apparent volume of distribution(V） and Half- life(t1/2）of IBI355(week 0-12)